This section illustrates useful background information without admission of any technique described herein representative of the state of the art.
New medical innovations, such as new drugs, medical devices, or medical applications, are often researched and tested using clinical trials. Trials require more than one phase of testing that take several years and cost considerable amounts of money to perform.
Clinical trials are typically classified into 4 phases (unless trial is interrupted or closed). Clinical trials of drugs may not fit into a single phase. For example, some clinical trials may blend from phase I to phase II or from phase II to phase III. The drug-development process may normally proceed through all four phases over many years. If a drug successfully passes through phases I, II and III, the drug may be approved by a national regulatory authority for use in general population, for example. Phase IV may correspond to ‘post-approval’ studies.
Each phase has a different purpose and helps researchers answer different questions. In phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time. The purpose is to evaluate its safety and identify side effects. In phase II trials, the experimental drug or treatment is administered to a larger group of people (100-300) to test its efficacy or effectiveness and to further evaluate its safety. In phase III trials, the experimental drug or treatment is administered to larger groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely. In phase IV trials, after a drug is approved by a regulatory authority, such as Food and Drug Administration (FDA) in the USA, and made available to the public, researchers track its safety, seeking more information about a drug or treatment's risks, benefits, and optimal use.
Typically, a clinical trial or study is funded by a sponsor, such as a private company, medical or research institution, federal agency, or by an entity established by a collaboration of such groups. The sponsor may employ one or more clinical investigators or research assistants to oversee administration of and/or monitor the study at one or more investigation sites. Each investigation site may include a number of study participants.
When a participant in a clinical trial fills in an electronic diary or study, a client device is used. The device may be used by a plurality of subject users one after another, clinical trial after another.
Traditionally, when a site coordinator sets up the client device to be handed over to the subject user, username and password are delivered to the subject user by email or simply typed or printed on paper. The client device with an application being used for processing and/or transceiving data relating to a clinical trial is set up and provisioned by site personnel and handed over to a subject user. Resetting currently authenticated user session before authentication of the next subject user may needed to be done manually by the site personnel.
Thus, a solution is needed to enable more secure and efficient resetting of earlier session data and providing credentials for the subject user when providing a client device to be used in a clinical trial.